Devices, methods, and sytems for shrinking tissues

ABSTRACT

Devices, systems, and method for treating urinary incontinence generally rely on energy delivered to a patient&#39;s own pelvic support tissue to selectively contract or shrink at least a portion of that pelvic support tissue so as to reposition the bladder. The energy will preferably be applied to the endopelvic fascia and/or an arcus tendineus fascia pelvis. The invention provides a variety of devices and methods for applying gentle resistive heating of these and other tissues to cause them to contract without imposing significant injury on the surrounding tissue structures. Alternatively, heat-applying probes are configured to heat tissue structures which comprise or support a patient&#39;s urethra. By applying sufficient energy over a predetermined time, the tissue can be raised to a temperature which results in contraction without significant necrosis or other tissue damage. By selectively contracting the support tissues, the bladder neck, sphincter, and other components of the urinary tract responsible for the control of urinary flow can be reconfigured or supported in a manner which reduces urinary leakage.

CROSS-REFERENCES TO RELATED APPLICATIONS

[0001] This application is a continuation of and claims the benefit ofpriority from U.S. patent application Ser. No. 09/598,076, filed Jun.20, 2000, which is a divisional of U.S. patent application Ser. No.08/910,370, filed Aug. 13, 1997 and now U.S. Pat. No. 6,091,995, whichis a continuation-in-part of U.S. patent application Ser. No.08/748,527, filed Nov. 8, 1996 and now abandoned, and U.S. patentapplication Ser. No. 08/862,875, filed May 23, 1997 and now abandoned,the full disclosures of which are incorporated herein by reference. Thisapplication is related to U.S. patent applications Ser. No. 08/910,775,now U.S. Pat. No. 6,480,746, Ser. No. 08/910,369, now U.S. Pat. No.6,035,238, and Ser. No. 08/910,371, now U.S. Pat. No. 6,081,749, allfiled Aug. 13, 1997, the full disclosures of which are also incorporatedherein by reference.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention generally relates to medical devices,methods, and systems. In a particular aspect, the present inventionprovides devices, methods, and systems for shrinking tissues, and whichare particularly useful for treatment of urinary incontinence in alaparoscopic or minimally invasive manner.

[0004] Urinary incontinence arises in both women and men with varyingdegrees of severity, and from different causes. In men, the conditionoccurs almost exclusively as a result of prostatectomies which result inmechanical damage to the sphincter. In women, the condition typicallyarises after pregnancy where musculoskeletal damage has occurred as aresult of inelastic stretching of the structures which support thegenitourinary tract. Specifically, pregnancy can result in inelasticstretching of the pelvic floor, the external vaginal sphincter, and mostoften, the tissue structures which support the bladder and bladder neckregion. In each of these cases, urinary leakage typically occurs when apatient's intra-abdominal pressure increases as a result of stress, e.g.coughing, sneezing, laughing, exercise, or the like.

[0005] Treatment of urinary incontinence can take a variety of forms.Most simply, the patient can wear absorptive devices or clothing, whichis often sufficient for minor leakage events. Alternatively oradditionally, patients may undertake exercises intended to strengthenthe muscles in the pelvic region, or may attempt behavior modificationintended to reduce the incidence of urinary leakage.

[0006] In cases where such noninterventional approaches are inadequateor unacceptable, the patient may undergo surgery to correct the problem.A variety of procedures have been developed to correct urinaryincontinence in women. Several of these procedures are specificallyintended to support the bladder neck region. For example, sutures,straps, or other artificial structures are often looped around thebladder neck and affixed to the pelvis, the endopelvic fascia, theligaments which support the bladder, or the like. Other proceduresinvolve surgical injections of bulking agents, inflatable balloons, orother elements to mechanically support the bladder neck.

[0007] Each of these procedures has associated shortcomings. Surgicaloperations which involve suturing of the tissue structures supportingthe urethra or bladder neck region require great skill and care toachieve the proper level of artificial support. In other words, it isnecessary to occlude the urethra or support the tissues sufficiently toinhibit urinary leakage, but not so much that normal intentional voidingof urine is made difficult or impossible. Balloons and other bulkingagents which have been inserted can migrate or be absorbed by the body.The presence of such inserts can also be a source of urinary tractinfections.

[0008] For these reasons, it would be desirable to provide improveddevices, methods, and systems for treating fascia, tendons, and othersupport tissues which have been strained, or which are otherwise toolong to provide the desired support. It would be especially desirable toprovide improved methods for treating urinary incontinence in men andwomen. In particular, it would be desirable to provide methods fortreating urinary incontinence in a minimally invasive manner with few orno percutaneous tissue penetrations, preferably utilizing laparoscopicor least invasive manner to minimize patient trauma. It would further bedesirable to provide incontinence treatment methods which rely on theexisting bladder support structures of the body, rather than dependingon the specific length of an artificial support. It would also bedesirable to provide methods which rely on introduction of a relativelysimple probe into the urethra or vaginal, where tissue structuressupporting or comprising the urethra may be caused to partially shrinkin order to inhibit urinary leakage.

[0009] 2. Description of the Background Art

[0010] Method and apparatus for controlled contraction of soft tissueare described in U.S. Pat. Nos. 5,569,242, and 5,458,596. An RFapparatus for controlled depth ablation of soft tissue is described inU.S. Pat. No. 5,514,130.

[0011] A bipolar electrosurgical scalpel with paired loop electrodes isdescribed in U.S. Pat. No. 5,282,799. U.S. Pat. No. 5,201,732 describesa bipolar sphincterotomy utilizing side-by-side parallel wires. Adisposable electrosurgical instrument is described in U.S. Pat. No.4,311,145. U.S. Pat. No. 5,496,312, describes an impedance andtemperature generator control.

[0012] The following patents and published applications relate to thetreatment of urinary incontinence. U.S. Pat. Nos. 5,437,603; 5,411,475;5,376,064; 5,314,465; 5,304,123; 5,256,133; 5,234,409; 5,140,999;5,012,822; 4,994,019; 4,832,680; 4,802,479; 4,773,393; 4,686,962;4,453,536; 3,939,821; 3,926,175; 3,924,631; 3,575,158; 3,749,098; and WO93/07815.

[0013] An electrosurgical probe for the controlled contraction oftissues of the joints and for dermatological indicators is described inU.S. Pat. No. 5,458,596. A bipolar electrosurgical probe havingelectrodes formed over a restricted arc of its distal end for treatmentof, e.g., the esophagus, is described in U.S. Pat. No. 4,765,331. Anelectrosurgical probe for retrograde sphincterotomy is described in U.S.Pat. No. 5,035,696. Other patents describing electrosurgical probesinclude U.S. Pat. Nos. 5,462,545; 5,454,809; 5,447,529; 5,437,664;5,431,649; 5,405,346; 5,403,312; 5,385,544; 5,370,678; 5,370,677;5,370,675; 5,366,490; 5,314,446; 5,309,910; 5,293,869; 5,281,218;5,281,217; 5,190,517; 5,098,429; 5,057,106; 4,807,620; 4,776,344;4,409,453; and 373,399.

[0014] The disclosure of the present application is related toco-pending U.S. patent application Ser. No. 08/610,911, filed on Mar. 5,1996, having a common inventor but assigned to a different entity.

SUMMARY OF THE INVENTION

[0015] The present invention provides improved devices, methods, andsystems for shrinking collagenated tissues, and particularly fortreating urinary incontinence. In contrast to prior art methods, thepresent invention does not rely on implantation of balloons or othermaterials, nor does it rely on suturing, cutting, or other directsurgical modifications to the genitourinary support tissues. Instead,the present invention relies on delivering energy to a patient's ownpelvic support tissue to selectively contract or shrink at least aportion of that pelvic support tissue, thereby raising the position ofthe bladder. The energy will preferably be applied across bipolarelectrodes to the endopelvic fascia and/or the arcus tendineus fasciapelvis. A variety of devices and methods are provided for applyinggentle resistive heating to these tissues without significant injury tothe support tissues, or to the surrounding tissue structures.

[0016] In a first aspect, the present invention provides a probe forheating and contracting fascia. The probe comprises a shaft having aproximal end and a distal end. First and second electrodes are disposednear the distal end of the shaft. These electrodes are simultaneouslyengageable against the fascia, and are separated by a predetermineddistance which limits a depth of tissue heating. A handle is adjacent tothe proximal end of the shaft for manipulating the electrodes fromoutside the patient body.

[0017] The bipolar probes of the present invention will generallyinclude a predetermined electrode diameter and electrode separationdistance to limit the depth of tissue heating, and will optionally havea temperature sensor mounted between the electrodes. The probe willoften be adapted to heat the fascia to temperatures significantly lessthan most known electrosurgical devices, and may include a controlsystem which limits the total electrical potential applied between thebipolar electrodes to much lower average power levels than knownelectrosurgical devices. In fact, the present heating probe may beconveniently energized with a battery pack carried in the proximalhandle of the probe.

[0018] In another aspect, the present invention provides a leastinvasive probe for heating and contracting fascia of a patient body. Thefascia is adjacent to a tissue layer, and the probe comprises a shafthaving proximal and distal ends. An electrode is disposed near thedistal end of the shaft and is laterally deployable from a narrowconfiguration to a wide configuration between the fascia and theadjacent tissue layer. The electrode in the wide configuration isexposed to engage the fascia. The electrode in the narrow configurationis disposed along an axis of the shaft to facilitate axial insertion ofthe probe. A handle is adjacent the proximal end of the shaft formanipulating the electrode from outside the patient body.

[0019] In yet another aspect, the present invention provides a probe forheating and contracting target tissues. The probe comprises a shafthaving a proximal end and a distal end. At least one electrode isdisposed near the distal end of the shaft. A handle is disposed adjacentthe proximal end of the shaft for manipulating the at least oneelectrode from outside the patient body. The handle supports a batteryand circuitry for energizing the at least one electrode with sufficientRF electrical potential to heat and contract the target tissue.

[0020] Circuitry for converting a direct current to an alternatingcurrent will often be coupled to the battery to provide heating whileavoiding nerve and/or muscle stimulation. In many embodiments, a controlsystem will be coupled to the electrode so that the target tissue israised to a temperature within a predetermined range. The temperature ofthe target tissue may be determined by a tissue temperature sensordisposed near the electrode (ideally being disposed between bipolarelectrodes) and/or by monitoring the impedance, resistance, or otherelectrical characteristics of the tissue/electrode circuit.

[0021] In another embodiment, the present invention provides a probe forshrinking collagenated tissue of a patient body. The probe comprises ashaft having a proximal end and a distal end. A grasper is disposed nearthe distal end of the shaft, and is adapted to draw a region of thetissue inward so as to reduce tension within the region. An energyapplying member is disposed adjacent to the grasper. The energy applyingmember is capable of heating the tissue while the tension is reduced sothat the tissue contracts, but without substantially ablating thetissue.

[0022] The present invention also provides a method to treat ahyperextending support tissue of a patient body. The hyperextendingtissue has a tissue depth, and the method comprises electricallycoupling the first electrode to the hyperextending tissue. A secondelectrode is also electrically coupled to the hyperextending tissue, andan electrical potential is applied across the electrodes whilecontrolling a separation between the first and second electrodes. As aresult of this separation control, an electrical current within thehyperextending tissue heats and shrinks the hyperextending tissue, butheating of tissue beyond the tissue depth is minimized.

[0023] The present invention also provides a method to treat urinarystress incontinence. The method comprises introducing a probe into apatient body and aligning the probe with a pelvic support tissue withinthe patient body. The probe is energized to heat and contract a portionof the pelvic support tissue.

[0024] In most embodiments, a portion of the pelvic support tissue isgently and resistively heated to between about 60° C. and 110° C., oftenbeing between about 60° C. and 80° C, by applying an electricalpotential across the electrodes, the electrodes being adapted to engagethe fascia surface. This gentle bipolar resistive heating will often betargeted at fascia. Such contraction of the fascia can raise and/orreposition the bladder within the patient body when the fascia is heatedto a depth of less than about 2.8 mm, preferably to a depth of less thanabout 2.0 mm, thereby minimizing collateral injury to the surroundingtissues. The heating depth can be precisely limited by controlling thediameter of the electrode surfaces (electrode surface diameter typicallyin the range from about 0.25 mm to about 4.0 mm, often being from about0.25 mm to about 2.0 mm) and the ratio of the spacing between theelectrodes to the electrode surface diameter (the spacing typicallybeing between about 1.0 and 4.0 times the surface diameter).Advantageously, a preferred separation distance of between about 2 and 3times the electrode surface diameters will provide an effective heatingdepth of about 2 times the electrode surface diameter. Surprisingly,sufficient RF energy for such targeted heating can be provided by abattery pack within a handle of the probe, the battery typicallyproviding between about 5 and 20 watts.

[0025] In a second aspect, the present invention provides an endoscopicmethod for treating urinary stress incontinence. The method comprisesintroducing a probe into a patient body, and optically imaging the probeand a target tissue. The target tissue comprises a portion of anendopelvic fascia or an arcus tendineus fascia pelvis. The electrode ispositioned against the target tissue, and energized to heat and contractthe target tissue, without substantially ablating the target tissue.

[0026] Once again, heating will often be limited in depth through theuse of a bipolar probe having a predetermined electrode diameter,spacing between the electrodes, and power. Heating can be monitoredand/or controlled, optionally using feedback from a temperature sensormounted between the electrodes. Advantageously, repeatedly sweeping theelectrodes across the endopelvic fascia can raise the bladder bydiscrete increments, typically by between about 0.1 and 3.0 mm with eachsweep of the electrodes.

[0027] In another aspect, the present invention provides a leastinvasive method for controllably shrinking fascia. The method comprisesinserting a probe into a patient body while the probe is in a narrowconfiguration. The probe has first and second electrodes, and isexpanded to a wider configuration to deploy at least one of the firstand second electrodes. The deployed electrodes are engaged against thefascia, and an electrical potential is applied across the electrodes toheat and contract the fascia disposed therebetween.

[0028] In yet another aspect, the present invention provides a methodfor treating a hernia. The hernia comprises a structure which protrudesthrough a containing tissue.

[0029] The method comprises applying sufficient energy to the containingtissue adjacent the hernia to heat the containing tissue so that thecontaining tissue contracts. The contraction mitigates the hernia, butthe heat does not substantially ablate the containing tissue.

[0030] In another aspect, the invention provides an abdominoplastymethod for tightening an abdominal wall. The abdominal wall comprises afascia, and the method comprises applying sufficient energy to theabdominal wall to heat the fascia so that the abdominal wall contracts.The heat is applied without substantially ablating the abdominal walland adjacent tissues.

[0031] In yet another aspect, the invention provides a method to treat ahyperextending collagenated support tissue of a patient body. The methodcomprises grasping a region of the hyperextending tissue and drawing thehyperextending tissue inward so as to decrease tension in the region. Atleast a portion of the drawn region is heated so that the regionshrinks, wherein the region is heated without substantially ablating thehyperextending tissue.

[0032] In yet another aspect, the invention provides a kit for shrinkinga target collagenated tissue within a patient body. The target tissuehas a tissue depth, and the kit comprises a probe and instructions foroperating the probe. The probe includes a shaft having a proximal endand a distal end. First and second electrodes are disposed near thedistal end of the shaft, the electrodes defining a separation distancetherebetween. The instructions include the steps of electricallycoupling the first and second electrodes with the target tissue, andheating and contracting the target tissue without ablating the targettissue by directing an electrical current flux through the target tissuebetween the electrodes. The separation distance substantially limitsheating beyond the target tissue depth.

[0033] In yet another aspect, the invention provides a kit for treatingurinary stress incontinence of a patient with a lax pelvic supportstructure. The kit comprises a probe having a heating element andinstructions for operating the probe. Instructions include the steps ofcoupling the heating element to the pelvic support structure, andapplying an amount of energy with the heating element to the pelvicsupport structure. The energy is sufficient to cause shrinkage of thepelvic support structure, and the shrinkage inhibits urinaryincontinence.

[0034] In yet another aspect, the invention provides a kit for treatinga hernia. The hernia comprises a structure which protrudes through acollagenated containing tissue. The kit comprises a probe having aheating element and instructions for operating the probe. Theinstructions include the steps of coupling the probe to the containingtissue, and applying an amount of energy from the probe to thecontaining tissue. The energy is sufficient to heat the containingtissue so that the containing tissue shrinks to mitigate the hernia.

[0035] In one exemplary embodiment of the present method, energy isapplied from within the patient's urethra, typically by inserting anenergy-applying probe into the urethra without having to employ anypercutaneous or transmucosal penetrations or incisions. When using sucha urethral probe, the energy will typically be applied directly to theurethral wall, either to a single location aligned with the urethralsling or to at least two sites including a first site upstream of theurethral sling and a second site downstream of the urethral sling. By“urethral sling,” we mean those supporting tendons and other tissuestructures which extend from the pubic bone downward beneath the urethraand urethral sphincter. Application of energy at such location(s) actsto shrink tissue adjacent the urethral lumen and to provide selective“kinks” or closure points at which the urethra can be closed.

[0036] In an alternative exemplary embodiment, energy-applying elementsare penetrated directly into the pubococcygeal muscles, theiliococcygeal muscles, and/or detrusor urinae muscles (and adjacentfascia) which support the urethra and urinary sphincter. By applyingenergy directly into these supporting muscles and tissue structures, themuscles can be contracted to provide improved urinary continence. Inparticular, sufficient muscular integrity can be provided so thaturinary leakage does not result from transient increases inintra-abdominal pressure as a result of stress. In the illustratedembodiment, the electrodes are penetrated into the target musclesthrough the vagina, typically using an introducer having an array ofextensible electrodes arranged to contact the target muscles and/ortendons.

[0037] In these exemplary embodiments, the energy will typically beapplied using an electrode capable of delivering radio frequency (RF)energy directly against the urethral wall or into the supporting tissuesin a monopolar or bipolar manner. In the first embodiment, electrodeswill usually be surface electrodes, i.e., adapted to contact the luminalwall of the urethra without penetration. In the second embodiment, theelectrodes are fashioned as needles or other penetrating members whichcan penetrate into the urethral wall by a desired distance. In additionto electrodes, the heat-applying elements can be optical fibers (fordelivery laser or other light energy), resistive heating elements,inductive heating elements, microwave heating elements, or any otherdevice which can be externally powered to heat tissue to thetemperatures and for the times discussed below.

[0038] The methods of the present invention may also be performed usingdevices and systems which access the treated tissue structures fromsites other than the urethra or vagina. For example, energy-applyingprobes can be introduced percutaneously from the patient's abdomen to adesired treatment site, for example the pubococcygeal muscle and tendon,or may alternatively be introduced through the rectum. Alternatively, infemale patients, the energy-applying probes can be transmucosallyintroduced through the vagina, as discussed above. For the purposes ofthe present invention, it is necessary only that the energy be deliveredto a target tissue structure in a manner which permits heating of thetissue to a desired temperature and for time sufficient to contract thetissue by a desired amount.

[0039] In addition to RF energy, the devices, systems, and methods ofthe present invention can rely on other energy sources, such asmicrowave, light (laser) energy, electrical resistance heating, thedelivery of heated fluids, the focusing of ultrasound energy, or anyother known energy delivery technique which can be targeted to specifictissue and raise the tissue temperature to the desired range.

[0040] When energy is applied directly to the luminal wall, it will bedesirable to control the resulting cross-sectional area of the urethra.Usually, the cross-sectional area will be reduced. Control of the amountof reduction can be effected, for example, by placing theenergy-applying elements, such as RF electrodes, on an expandable memberwhich can initially be expanded to contact the elements against theluminal wall. As the luminal wall shrinks, the cross-section area of theexpandable member can also be reduced. Alternatively, in instances wherethe energy is being applied to contract adjacent tissue structures, itmay be necessary to further expand the expandable member carrying theelectrodes to maintain contact. A variety of specific configurations canbe utilized.

[0041] In some embodiments, devices according to the present inventionwill comprise a probe body having a proximal end and a distal end. Thebody will preferably have a length and diameter selected to permitintroduction into the urethra or vagina so that the distal end can bepositioned adjacent to the urethral sling or target tissues. One or moreelectrodes are disposed on the distal end of the probe body to applyenergy into the urethral wall in the region of the urethral sling and/orinto the tissue structures which support the urethral sling. A connectoris provided on the proximal end of the probe body to permit connectionto an appropriate power supply. The probe body will typically have alength in the range from 5 cm to 20 cm with electrode lengths in therange from 0.3 cm to 7 cm. The probe body will usually have a diameterin the range from 1 mm to 6 mm. The body will usually be flexible, butcould also be rigid. The body should have sufficient torsional rigidityto permit rotational orientation and alignment of the probe within theurethra. The probe will include at least a single electrode, and willoften include two or more electrodes which can be connected to the powersupply in a monopolar or a bipolar fashion. The electrodes may besurface electrodes (for engaging the urethra wall) or tissue-penetratingelectrodes for applying energy into the urethra-supporting tissues. In aspecific embodiment, the probe will include two axially-spaced apartelectrodes which are positioned and configured so that they will bealigned on the upstream and downstream sides of the urethral sling whenapplying energy within the urethra. The probe may further comprise anexpansion member, such as an expandable balloon, carrying at least oneof the electrodes on the catheter body. In a second specific embodiment,the probe includes an array of extensible, tissue-penetration electrodesdisposed to penetrate target tissues from the vagina.

BRIEF DESCRIPTION OF THE DRAWINGS

[0042]FIG. 1 is a perspective view of a bipolar battery operated probefor laparoscopically heating and contracting fascia, according to theprinciples of the present invention.

[0043]FIG. 2 is a schematic of the functional components of the probe ofFIG. 1.

[0044]FIG. 3 is a lateral cross-sectional view showing the urinarybladder and bladder support structures.

[0045]FIG. 4 is a simplified cross-sectional view of the pelvis showingthe endopelvic fascia and arcus tendineus fascia pelvis, and illustratesa method for treating urinary stress incontinence by sweeping the probeof FIG. 1 across the endopelvic fascia to reposition and/or raise theurinary bladder.

[0046]FIG. 5 is a cross-sectional view of a patient suffering fromurinary stress incontinence due to inelastic stretching of theendopelvic fascia.

[0047]FIG. 6 shows a known method for treating urinary stressincontinence by affixing sutures around the bladder neck.

[0048]FIG. 7 illustrates improved bladder support provided byselectively contracting the endopelvic fascia as a therapy for urinarystress incontinence, according to the principles of the presentinvention.

[0049]FIG. 7A illustrates a patient suffering from a cystocele in whichthe bladder protrudes into the vagina, and which may be treated byselectively contracting the pelvic support tissues using the methods ofthe present invention.

[0050]FIG. 8 illustrates how the controlled spacing between the bipolarelectrodes of the probe of FIG. 1, relative to the electrode diameter,limits the depth of tissue heating.

[0051]FIG. 9 schematically illustrates repeatedly sweeping the bipolarelectrodes of the probe of FIG. 1 across the endopelvic fascia to raisethe urinary bladder in a series of discrete increments.

[0052] FIGS. 10-12D illustrate alternative electrode configurations foruse with the probe of FIG. 1.

[0053]FIGS. 13A and 13B illustrate bipolar electrodes which moverelative to each other when tissue contracts to provide feedback and/orlimit tissue heating, according the principle of the present invention.

[0054]FIG. 13C illustrates an electrode structure that varies theheating depth with the rotational position of the probe about the axisof the probe.

[0055]FIG. 14 illustrates a bipolar fascia contracting probe havingroller electrodes to facilitate sweeping the probe over the fascia.

[0056]FIG. 15 illustrates a joystick actuated least invasive probe forpenetrating through the vaginal mucosa to the mucosa/fascia interface,the endopelvic fascia surface, or the vesical-vaginal space, the probehaving an asymmetric handle to indicate the electrode orientation,according the principles of the present invention.

[0057] FIGS. 15A-15D illustrate least invasive methods for accessing theendopelvic fascia through the vaginal mucosa or the bladder wall.

[0058]FIG. 16 illustrates an asymmetric least invasive probe havingbipolar electrodes which are deployable by inflating a balloon.

[0059]FIGS. 17A and 17B schematically illustrate self-orientation of theinflatable electrode assembly of the probe of FIG. 16.

[0060]FIGS. 18A and 18B schematically illustrate the deployment ofbipolar electrodes by inflating an asymmetric flat balloon with twodifferent inflation media to radiographically verify the orientation ofthe electrodes.

[0061]FIG. 19 illustrates the deployed state of an alternative balloondeployable electrode configuration for use with the least invasive probeof FIG. 15.

[0062] FIGS. 20A-20C schematically illustrate the deployed state of aballoon having alternating electrodes, and a method for its use toseparate a fascia targeted for contraction from an adjacent tissuesurface, after which the balloon is partially deflated for heating andcontracting the fascia.

[0063]FIGS. 21A and 21B schematically illustrate bipolar electrodeswhich are supported along resilient elongate structures, in which theelongate structures are biased to separate the electrodes, for use withthe least invasive probe of FIG. 15.

[0064] FIGS. 22A-22C schematically illustrate an alternative electrodedeployment structure in which a pull-wire deflects elongate structuresto deploy the electrodes.

[0065] FIGS. 23A-23C schematically illustrate an electrode deploymentstructure in which a central member is tensioned to deflect theelectrode support structures resiliently outwardly.

[0066]FIG. 24 is a perspective view of an alternative probe forshrinking endopelvic fascia and other collagenated tissues, in which theprobe includes a grasper which reduces tension in the region of tissueto be contracted to enhance shrinkage.

[0067]FIGS. 25A and 25B schematically illustrate a method for using theprobe of FIG. 24 by grasping the target tissue and drawing a region ofthe target tissue inward to reduce tension in the engaged tissue, andthereby enhance shrinkage.

[0068] FIGS. 26-26C are cross-sectional views of a patient sufferingfrom a hiatal hernia showing a method for treatment using the probes ofthe present invention.

[0069]FIG. 27 illustrates a patient suffering from an inguinal hernia,and identifies regions for treating the inguinal hernia using themethods of the present invention.

[0070]FIG. 28 is a perspective view of an exemplary electrosurgicalprobe constructed in accordance with the principles of the presentinvention.

[0071] FIGS. 28A-28D illustrate alternative electrode configurations forthe probe of FIG. 28.

[0072]FIG. 29 illustrates a distal probe tip having an expandableballoon carrying an electrode array.

[0073]FIG. 30 illustrates a system comprising the probe of FIG. 28 and apower supply performing a procedure in a patient's urethra.

[0074]FIG. 31 illustrates a second exemplary electrosurgical probeconstructed in accordance with the principles of the present invention.

[0075]FIG. 32 is a detailed distal end view of the probe of FIG. 31.

[0076]FIG. 33 is a detailed distal side view of the probe of FIG. 31.

[0077] FIGS. 34-37 illustrate the use of the probe of FIGS. 31-33 inperforming a procedure in a patient's vagina.

[0078]FIG. 38 schematically illustrates a kit including a laparoscopictissue contraction probe, packaged together with pointed instructionsfor its use to contract tissue as a treatment for urinary incontinence.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

[0079] The present invention generally provides devices, methods, andsystems which can selectively shrink fascia and other collagenatedtissues. By directing an electrical current flux through such a tissue,ideally between bipolar electrodes directly engaging the tissue, theelectrical resistance of the tissue can induce gentle heating andcontraction of the tissue without significant injury to the adjacenttissues. Controlling a diameter of the electrode surfaces and a ratio ofthe surface diameter to a separation distance between the electrodes canlimit the depth of heating, while electrode surface shape and size willhelp determine heating at the electrode/tissue interface. The presentinvention is particularly welt adapted for contraction of fascia andligaments, and may therefore have applications in a variety oftherapies, including traditional and minimally invasive therapies of thepelvis, thorax, and joints. These devices, methods, and systems areadaptable for therapies of specific tissues and conditions includinghiatal hernias, abdominal hernias, cystocele, enterocele, rectocele, anduterovaginal prolapse. The present invention will find its mostimmediate application for the treatment of urinary stress incontinence.In many embodiments, the present invention will effect contraction of apelvic support tissue to raise a position of the bladder, particularlyafter the pelvic support tissues have been stressed by pregnancy.Related devices and methods are described in co-pending U.S. patentapplication Ser. No. 08/910,775, filed herewith (Attorney Docket No.17761-000300), the full disclosure of which is incorporated herein byreference.

[0080] In general, the present invention is well adapted for treatmentof any hyperextending collagenated tissue. As used herein, the term“hyperextending” encompasses any tissue structure which is excessive inat least one dimension, so that a support function of the tissue iscompromised. This excessive length, etc., may be the result of injury,pregnancy, disease, age, a congenital defect, a tear or partial tear, orthe like.

[0081] Referring now to FIG. 1, a tissue contraction probe 10 includes ashaft 12 having a proximal end 14 and a distal end 16. First and secondelectrodes 18, 20 are disposed near distal end 16 of shaft 12, while ahandle 22 is disposed at the proximal end of the shaft. A switch 24applies a radiofrequency electrical potential across first and secondelectrodes 18, 20 to effect gentle resistive heating of electricallyconductive tissues which span these electrodes. Surprisingly, powerrequirements of this targeted bipolar resistive heating are so low thata battery pack contained within handle 22 can sufficiently energizefirst and second electrodes 18, 20.

[0082] As can be understood with reference to FIG. 2, a battery pack 26energizes probe 10, typically providing a relatively low power radiofrequency current. The direct current of the battery is converted to thedesired radio frequency by a DC to AC converter of a RF generator 28.The electrical potential applied to first and second electrodes 18, 20will typically be between about 200 and 1,000 KHz, and will typicallyhave an amplitude of between about 10 and 100 volts ac rms. Such lowpower heating will substantially avoid arcing between the electrode andthe tissue surface, further decreasing the injury to these tissues, andalso providing safety to the operator. The RF electrical heating willalso desiccate the tissue, increasing its resistance. Since the appliedvoltage is too low to cause arcing, the delivered power will decrease asthe tissue dries, so the tissue damage is superficial and self limiting.This makes treatment less subject to operator error.

[0083] A heating controller 30 will often limit at least one of thefollowing: the temperature of the target tissue, the shrinkage of thetissue between the electrodes, and/or the time the target tissue ismaintained at an elevated temperature. In some embodiments, tissueheating temperatures will be measured directly using a temperaturesensor 32 mounted to the probe between the first and second electrodes18, 20, or separately inserted into the tissue via an ultrasonically orfluoroscopically guided temperature probe. Alternatively, tissuetemperature, contraction, and the like may be determined indirectly bymonitoring the electrical characteristics of the tissue itself. In otherwords, by monitoring the circuit during heating, the tissue resistivity,resistance, capacitance, or the like, can be calculated. From thesevalues, and optionally by monitoring the changes in these electricalcharacteristics, it may be possible to estimate the temperature ordegree of desiccation of the tissue, the amount of shrinkage which hasoccurred, and the like. Preferably, controller 30 will limit the heatingof tissues to a temperature range of between about 60° C. and 110° C.,ideally to between about 60° C. and 80° C.

[0084] Alternatively, it may be possible to simply limit the electricalpotential applied across the electrodes thereby permitting normalthermal conduction to control the maximum temperature. In fact, in someembodiments, a simple timer may be coupled to switch 24, so that alimited amount of energy is applied across first and second electrodes18, 20, thereby avoiding over-treatment (particularly during spottreatments, as described hereinbelow). The physician simply energizesthe time limited circuit after each movement of the electrodes, therebyavoiding unintended over-treatment, and also helping to ensure thatsufficient energy is delivered for treatment of each site.

[0085] While the exemplary embodiment incorporates battery pack 26 andcontroller 30 into handle 22, it should be understood that theenergizing and control functions may be provided by structures which areexternal to probe 10. In such embodiments, couplers for connectingelectrodes 18 and 20 to a power source, control circuitry, and the like,will often be provided on housing 22. Battery pack 26 may optionallyinclude two or more batteries. As used herein, a battery may be a singlecell or a series of cells, where each cell is a substantiallyself-contained D.C. energy source.

[0086] The pelvic support tissues which generally maintain the positionof the urinary bladder B are illustrated in FIG. 3. Of particularimportance for the method of the present invention, endopelvic fascia EFdefines a hammock-like structure which extends between the arcustendineus fascia pelvis ATFP, as can be understood with reference toFIG. 4, these latter structures extend substantially between theanterior and posterior portions of the pelvis, so that the endopelvicfascia EF largely defines the pelvic floor.

[0087] In women with urinary stress incontinence due to bladder neckhypermobility, the bladder has typically dropped between about 1.0 and1.5 cm (or more) below its nominal position. This condition is typicallydue to weakening of the pelvic support structures, including theendopelvic fascia, the arcus tendineus fascia pelvis, and thesurrounding ligaments and muscles, often as the result of bearingchildren.

[0088] When a woman with urinary stress incontinence sneezes, coughs,laughs, or exercises, the abdominal pressure often increasesmomentarily. Such pressure pulses force the bladder to descend stillfurther, shortening the urethra UR and momentarily opening the urinarysphincter.

[0089] As can be most clearly understood with reference to FIGS. 3-7,the present invention generally provides a therapy which applies gentleheating to shrink the length of the support tissues and return bladder Bto its nominal position. Advantageously, the bladder is still supportedby the fascia, muscles, ligaments, and tendons of the original pelvicsupport tissues. Using gentle resistive heating between bipolarelectrodes, the endopelvic fascia EF and arcus tendineus fascia pelvisATFP are controllably contracted to shrink them and re-elevate thebladder towards its original position.

[0090] Tissue contraction with probe 10 will generally be performed inat least one of two modes: spot treatments and line treatments. Forexample, by engaging the arcus tendineus fascia pelvis at asubstantially fixed location with first and second electrodes 18, 20, adiscrete portion along that substantially linear structure can be gentlyheated for a few seconds to the target temperature range. The toughfibrous tendon will then shorten, raising the endopelvic fascia EFwhich, in turn, raises the overall position of bladder B. Suchcontractions of a discrete region about a fixed engagement location areherein called spot treatments.

[0091] To provide a line treatment, the distal end of probe 10 is sweptacross endopelvic fascia EF laterally or linearly, as illustrated inFIG. 4. As the electrodes engage the adjacent endopelvic fascia, theyraise the temperature of the adjacent tissues, resulting in a line ofcontracted tissues behind and between the electrode paths.Advantageously, this line of fascia contraction increases the overalltautness of the endopelvic fascia, again raising the overall position ofbladder B. This is an example of the use of a single line treatment toeffect repositioning of the bladder.

[0092] Advantageously, repeatedly sweeping probe 10 across adjacentareas of the endopelvic fascia can raise the bladder in discreteincrements. For example, if first and second electrodes 18, 20 areseparated by a space of about 3.0 mm, and if the fascia shrinks by about50% with it each sweep of probe 10, the physician can re-elevate bladderB about 1.5 cm with between 10 and 15 line treatments of the endopelvicfascia. Similar results may be provided by 10 to 15 spot treatments ofthe arcus tendineus fascia pelvis, or by some combination of spot andline treatments.

[0093] Access to and direction of the therapy, as schematicallyillustrated in FIG. 4, will often be provided by the minimally invasivemethods and devices that have recently been developed. In manyembodiments, a laparoscope 34 will allow direct optical imaging, oftenwhile the pelvic region is distended using gas insufflation. The presentmethods may be optically directed using a variety of existing endoscopicstructures, depending on the treatment site and access approach.Laparoscopes, arthroscopes, hysteroscopes, or the like may be used (oradapted for use) in the present methods. Alternatively, conventionaloptical imaging capabilities may be incorporated into probe 10, orspecialized fiber optic image guides may be used, either separated fromor incorporated into probe 10. In some embodiments, the therapy may bedirected using a remote imaging modality, such as fluoroscopy,ultrasound, magnetic resonance imaging, or the like. It is also possibleto take advantage of the controlled tissue contraction of the presentinvention in a more traditionally invasive therapy.

[0094] Referring now to FIG. 5, bladder B can be seen to have droppedfrom its nominal position (shown in phantom by outline 36). Whileendopelvic fascia EF still supports bladder B to maintain continencewhen the patient is at rest, a momentary pulse P opens the bladder neckN resulting in a release through urethra UR.

[0095] A known treatment for urinary stress incontinence relies onsutures S to hold bladder neck N closed so as to prevent inadvertentvoiding, as seen in FIG. 6. Sutures S may be attached to bone anchorsaffixed to the pubic bone, ligaments higher in the pelvic region, or thelike. In any case, loose sutures provide insufficient support of bladderneck N and fail to overcome urinary stress incontinence, whileovertightening of sutures S may make normal urination difficult and/orimpossible.

[0096] As shown in FIG. 7, by selectively contracting the natural pelvicsupport tissues, bladder B can be elevated from its lowered position(shown by lowered outline 38). A pressure pulse P is resisted in part byendopelvic fascia EF, which supports the lower portion of the bladderand helps maintain the bladder neck in a closed configuration. In fact,fine-tuning of the support provided by the endopelvic fascia is possiblethrough selective contraction of the anterior portion of the endopelvicfascia to close the bladder neck and raise bladder B upward.Alternatively, lateral repositioning of bladder B to a more forwardposition may be effected by selectively contracting the dorsal portionof endopelvic fascia EF. Hence, the therapy of the present invention maybe tailored to the particular weakening exhibited by a patient's pelvicsupport structures.

[0097] Another condition which is suitable for treatment using themethods of the present invention is illustrated in FIG. 7A. In thispatient, a posterior portion PP of bladder B protrudes into vagina V sothat an acute angle is formed by the posterior wall of the urethra andthe anterior wall of the urinary bladder. Such a condition, generallyreferred to as cystocele, may be effectively treated by selectivelycontracting the endopelvic fascia and/or other pelvic support tissuesand repositioning the bladder as described above. Additional conditionswhich may be treated using the methods of the present invention includeenterocele (a hernial protrusion through a defect in the rectovaginal orvesicovaginal pouch), rectocele (prolapse or herniation of the rectum),and uterovaginal prolapse (downward movement of the uterus so that thecervix extends into or beyond the vaginal orifice, usually from injuriesduring childbirth or advanced age). For each of these conditions, themethods of the present invention generally make use of the naturalsupport tissues within the pelvis, generally by selectively contractingthose support tissues to reposition and/or contain the displaced organs.As will be described in more detail hereinbelow, herniated structuresmay be treated at least in part by repositioning the protrudingstructures behind the tissue which nominally contain them, and thenselectively contracting the containing tissues to prevent reoccurrenceof the hernia.

[0098] Referring now to FIGS. 8 and 9, a depth D of the endopelvicfascia EF (and adjacent tissue T) heated by bipolar probe 10 will dependon the power applied, on a spacing S between first and second electrodes18, 20, and on the surface diameter 39 of the electrodes. Generally,spacing S will be between about 0.25 and 4.0 mm. More specifically,spacing S will preferably be in the range from about 1 to 4 times theelectrode diameter 39, with the electrode diameter often being betweenabout 0.25 and 4.0 mm, preferably being between about 0.25 and 2.0 mm,and ideally being between 0.25 and 1.0 mm. This will limit the heatingdepth D to generally less than about 2.0 mm, and often to less than 1.0mm. Advantageously, the temperature gradient along the edge of thetreatment zone is quite steep. By such selective heating of theendopelvic fascia EF, collateral damage to the underlying tissues T islimited. Fascia will contract when heat is applied by such a structurefor a very short time, the target tissue ideally being heated for a timein a range from about 0.5 to 5 seconds. In general, selectivelytargeting the fascia adjacent the surface maximizes the tissuecontraction provided by heating, and greatly limits necrosis, lesioning,and other collateral injuries to the vaginal mucosa and the musculartissues which help to support the bladder in the desired position. Asmore fully explained in application Ser. No. 08/910,775 (Attorney DocketNo. 17761-000300), the electrodes may be cooled to prevent injury to theengaged tissue surface. Cooling may be provided, for example, by formingthe electrodes of thermally conductive tubing, and by running a coldfluid through the tubing.

[0099] As illustrated in FIG. 8, a film 41 of saline, either natural orintroduced, may be disposed over the engaged tissue surface. Film 41prevents the electrode surfaces from sticking to the engaged tissue, andcan also provide a more even impedance and/or power through thecircuitry. Drying of the tissue surface due to CO2 insufflation may beavoided by providing a saline irrigation of about 1 cc/min. during thetissue contraction procedure.

[0100] While spacing S will often be fixed, it should also be understoodthat the separation between the first and second electrodes mayoptionally be varied to controllably vary the heating depth D.

[0101] The sweeping of first and second electrodes 18, 20 of probe 10over the endopelvic fascia EF to discretely raise the bladder can beunderstood with reference to FIG. 9. The endopelvic fascia EF is heatedand contracted by the passing electrodes, the fascia typicallycontracting by an amount within the range between about 30 and 50%. Asthe electrodes sweep across the fascia surface, they define electrodepaths 40. The electrode paths are closer together after probe 10 hasswept by, so that the overall width of the endopelvic fascia decreasesby an amount of between about 0.3 and 0.5 times electrode spacing S eachtime probe 10 sweeps over untreated fascia (in our example). Hence, thetotal distance that the bladder is raised can be varied by varying thenumber of sweeps of probe 10. The probe will preferably sweep adifferent section of the endopelvic fascia each time, as fascia whichhas previously been contracted will undergo only a more limitedcontraction. Hence, probe 10 will often be moved axially by an amount ofat least the electrode spacing S prior to each sweep.

[0102] A variety of alternative electrode configurations are illustratedin FIGS. 10-12D. FIG. 10 illustrates a probe 42 which is otherwisesimilar to probe 10 of FIG. 1, but which includes first and secondinterleaved helical electrodes 44, 46. These electrodes alternate aboutthe distal end of helical probe 42 in a “barber pole” configuration.This allows a greater amount of shrinkage each time helical probe 42engages a fascia or ligament surface, as heating will be providedbetween each span of the tissue between adjacent electrodes, and alsoeliminates any need for angular alignment of the probe. Advantageously,spacing S remains substantially uniform over the probe surface.

[0103] Distally oriented probe tip 48 includes first and second distallyoriented electrodes 50, 52 which are again separated by spacing S. Thisstructure is particularly well-suited for contracting tissues havingsurfaces which are oriented normal to the axis of the probe, and forspot contraction of certain tissue bands (such as ligaments). Anaxially-ended probe tip 54 includes alternating first and secondaxially-ended ribbon or wire electrodes 56, 58, and is adapted forengaging both laterally and proximally oriented tissue surfaces. Notethat axial first and second electrodes 56, 58 may comprise ribbonstructures or wires which are inset into axially-ended electrode tip 54,thereby avoiding inadvertent engagement of tissues adjacent the targettissue surface. Sensor 32 optionally measures the temperature of thetarget tissue.

[0104] In some embodiments, the electrode structures on the probes ofthe present invention will provide feedback to the probe regarding theamount of tissue contraction. Referring now to FIG. 13A, a moveableelectrode probe 60 includes rotatable first and second electrodes 62, 64which roll about a shaft 66 to facilitate sweeping of the electrodesover the target surface. The electrodes also include radial protrusions,presenting a structure which looks somewhat like a gear with pointedteeth. The protrusions minimize sliding between the electrode surfaceand the target tissue surface. Hence, as the engaged tissue contractsalong the axis of shaft 66, it draws the first and second rotatableelectrodes 62, 64 together.

[0105] By measuring the displacement between first electrode 62 andsecond electrode 64, moveable electrode probe 60 provides an indicationof the total tissue shrinkage. The attending physician or an electronicelectrode energizing control circuit may make use of this feedback tocontrol tissue heating. Alternatively, the probe may measure the forcethe contracting tissue imposes on the electrodes without allowing anyactual displacement of one electrode relative to the other. Such astructure would maintain the fixed spacing S between the electrodes.

[0106] An even simpler feedback mechanism is illustrated in FIG. 13B.Spot contraction probe 70 includes first and second shortable electrodes72, 74 which will contact each other when the engaged tissue iscontracted by a predetermined amount. The shorting of the electrodeswill often provide a signal terminating the energizing of theelectrodes. The electrodes will optionally have protrusions 76 whichpress into the tissue surface to avoid sliding.

[0107] Those with skill in the art will realize a variety of mechanismsmay be used to measure shrinkage of the tissue, including fiber opticmeasuring mechanisms, microswitches, strain gauges, or the like.However, the electrode structure illustrated in FIG. 13B has theadvantage that the shorting of the electrodes automatically terminatesheating, allowing the device to both measure and control shrinkage witha very simple structure.

[0108] In some embodiments, a variable spacing between first and secondbipolar electrodes may allow the surgeon to control the depth ofheating. For example, as illustrated in FIG. 13C, rotating a variablespacing probe 80 allows the physician to engage a target tissue surfacewith alternate portions of angled electrodes 82, 84 to vary an effectivespacing ES therebetween. Note that local electrode surface diameters ofangled electrodes 82, 84 vary with separation, so that a ratio ofelectrode separation ES to local surface diameter remains about 2 to 1.Clearly, more complex spacing varying mechanisms are also possible.

[0109] A wide variety of alternative electrode structures are alsopossible. Referring now to FIG. 14, a still further alternativeembodiment of the present laparoscopic or endoscopic probe 90 has firstand second partially enclosed roller electrodes 92, 94 for rollingagainst tissue surface without inadvertently engaging the surroundingtissues. More than two rollers may be used, with the polarity of theelectrodes generally alternating (as can be understood with reference toFIGS. 10-12B). Such alternating electrodes may instead be defined byaxial wires or ribbons in a straight configuration, or may curve inalternating spirals at the distal end of the probe. In some embodiments,the electrodes may be defined by the ends of coaxial tubes withinsulating material between the tubes and over the outer tube.

[0110] While the shafts supporting the electrodes of the presentinvention are generally shown as straight structures, many of theseembodiments may alternatively incorporate bends in the shafts betweenthe proximal and distal ends. Alternatively, the shafts may bearticulated to facilitate engaging the target tissue surface. Hence, thepresent invention encompasses not only straight shafts, but shafts whichare slanted, angled, articulated, flexible, inflatable, or the like, tofacilitate engaging a target tissue from the selected approach position.

[0111] Referring now to FIG. 15, a least invasive probe 100 includes adistal needle 102 to facilitate inserting an articulated shaft 104 andaccess the fascia supporting the pelvic floor. The device will typicallygain access to this treatment site by percutaneous insertion through theskin of the abdomen, through the wall of the vagina, or through theurethra. A joystick 106 manipulates articulated shaft 104, which canfacilitate positioning the electrodes against the target tissue.Optionally, joystick 106 may also be used to direct needle 102 topenetrate the vagina mucosa or bladder surface.

[0112] Methods for accessing endopelvic fascia EF using least invasiveprobe 100 are illustrated in FIGS. 15A-15C. Shaft 104 is inserted in thevagina and placed against the anterior surface. Needle 102 perforatesthe vaginal mucosa VM, optionally extending through endopelvic fascia EFto lay adjacent to (and in contact with) the endopelvic fascia betweenthe endopelvic fascia and bladder B in the vesical-vaginal space 101.Alternatively, needle 102 may be directed through vaginal mucosa VMwithout perforating endopelvic fascia EF to lay in contact with theendopelvic fascia between the endopelvic fascia and the vaginal mucosa.In either case, once least invasive probe 100 has accessed endopelvicfascia EF, one or more electrodes will engage and heat the fascia toinduce contraction. In some embodiments, a two-pronged needle probecould be used, with each needle having an electrode surface tofacilitate bipolar resistive heating. Alternatively, the needle may beremoved from the positioned least invasive probe 100 and replaced with adeployable electrode structure, as described hereinbelow.

[0113]FIG. 15D illustrates a still further alternative method foraccessing endopelvic fascia EF. In this embodiment, a cystoscope 105 isinserted through urethra UR into bladder B. A curved needle 103punctures through the bladder wall with a retrograde orientation, theneedle preferably being clear of the ureteral vesical junctions andtrigon. Curved needle 103 is again positioned in contact with endopelvicfascia EF on the anterior surface of the vagina. Such a method may makeuse of an off-the-shelf cystoscope.

[0114] Least invasive probe 100 will often be positioned using a remoteimaging mechanism, typically in a fluoroscopically or ultrasonicallydirected procedure. To help ensure that the electrodes of least invasiveprobe 100 are properly oriented toward the target tissue, asymmetrichandle 108 will often be rotationally affixed relative to the electrode.In some embodiments, electrodes may simply be positioned on the surfaceof articulatable shaft 104, on needle 102, or the like. However, tominimize the cross-section of 104 so as to facilitate percutaneousinsertion, it will often be advantageous to include an electrode supportstructure which is deployable from the shaft once the electrodes arepositioned adjacent the target surface. Such a deployable electrodestructure may optionally be inserted through articulated shaft 104 afterremoval of needle, 102, or may instead be incorporated into the distalend of articulated shaft 104.

[0115] An example of a deployable electrode structure is illustrated inFIG. 16. Balloon system 110 includes a shaft 112 having an angularposition indicating line 114. Line 114 helps to indicate the orientationof a distal balloon 116 from the proximal end of the balloon system. Inother words, line 114 allows the physician to verify that first andsecond balloon electrodes 118, 120 are properly oriented to engage thetarget tissue.

[0116] The use of balloon system 110 will be explained with reference toFIGS. 16, 17A and 17B. Balloon 116 is inserted between the endopelvicfascia EF and an adjacent tissue AT while the balloon system is in anarrow diameter configuration. In the narrow configuration, balloon 116is deflated and the electrodes are disposed along shaft 112. Once thedeflated balloon is at the desired location, the balloon may be roughlyrotationally positioned with reference to line 114 on shaft 112. Balloon116 can then be inflated through inflation port 122 on proximal balloonhousing 124. As the balloon inflates, it separates endopelvic fascia EFfrom adjacent tissue AT. Additionally, as balloon 116 defines asubstantially flat structure when inflated, it will tend to self-orient,so that first and second balloon electrodes 118, 120 engage theendopelvic fascia as shown in FIG. 17B.

[0117] In some embodiments, balloon 116 is bilaterally asymmetric tohelp verify the orientation of the deployed electrodes. The asymmetricfeature of balloon 116 may comprise simple radiopaque or ultrasonicallyimageable markers, differing first and second electrode shapes, or thelike. In the embodiment illustrated in FIG. 17B, the balloon isasymmetrically mounted to shaft 112. When viewed under fluoroscopy,ultrasound, or the like, this asymmetry helps verify the position andorientation of the electrodes.

[0118] Once the first and second balloon electrodes 118, 120 arepositioned, the electrodes may be energized through electrical coupler126. A third connector 128 on proximal housing 124 may be used fordirecting insertion of the balloon with a guidewire, gas insufflation,optical imaging, or the like.

[0119] A wide variety of alternative balloon configurations may be used.For example, a two-part balloon 130 may be filled in-part with aradiopaque liquid 132, and in-part with a non-radiopaque gas or liquid134, as can be understood with reference to FIGS. 18A and B. Underremote imaging, gas 134 and liquid 132 may be easily distinguished toverify the orientation of the electrodes.

[0120] To enhance tissue contraction, it may be convenient to include alarger number of electrodes on the least invasive probe structure.Typically, these electrodes will be arranged as alternating bipolarstructures, as can be understood with reference to FIGS. 19-20C. In someembodiments, the electrodes may be selectively energizable to vary theamount of contraction, and to direct the resistive heating to the targettissue without rotating the probe to a specific orientation. A barberpole balloon 140 having electrodes similar to the structure illustratedin FIG. 10 is shown in FIG. 19.

[0121] The balloon structures of the present invention need notnecessarily be flat. For example, as illustrated in FIGS. 20A-C, acylindrical balloon 150 may be inflated to separate the fascia from theadjacent tissue, and to enhance engagement of at least some of theelectrodes against the fascia. By selectively energizing the electrodeswhich engage the endopelvic fascia, collateral damage to the adjacenttissues may be avoided. As illustrated in FIG. 20C, cylindrical balloon150 may be partially deflated to avoid distention of the endopelvicfascia during heating, and thereby enhance contraction. Such partialdeflation may also increase the number of electrodes which engage thetarget tissue.

[0122] Still further alternative deployable electrode support structuresare illustrated in FIGS. 21A-23C. For example, a self-spreadingelectrode system 160 includes a sheath 162 which restrains elongatefirst and second electrode support structures 164, 166. Once theself-spreading system is positioned at the treatment site, sheath 162 iswithdrawn proximally (or atraumatic tip 168 is advanced distally). Theresilient support structures separate laterally when released fromsheath 162, thereby deploying restrainable electrodes 170, 172.Optionally, a web 171 between the electrodes limits the separation ofthe electrodes to the desired distance. A similar deployable electrodestructure may include elongate electrode support structures which arenominally straight, but which may be laterally displaced by a pull wire174 to deploy the electrodes, as illustrated in FIGS. 22A-C.

[0123] Still further alternative deployable electrode structures arepossible. As illustrated in FIGS. 23A-C, lateral deployment of flatelectrode support structures 180 may be effected by drawing a middlemember 182 proximally. Fasteners 184 support the structures, andinteract with a slot 186 in middle member 182 to limit axial movement ofthe middle member and thereby control the spacing between the deployedelectrodes.

[0124] As explained above, thermocouples or other temperature sensorsmay be incorporated into the least invasive probes of the presentinvention, preferably between the bipolar electrodes. Feedback controlmay alternatively be provided by monitoring the energizing circuit, aswas also explained above. Those of skill in the art will recognize thatballoon electrode support structures may make use of single lumen, ormultiple lumen shafts for inflation, energizing wires, temperaturesensing feedback, guidewires, gas or fluid insertion, and the like.

[0125] A grasping probe 190 is illustrated in FIG. 24. Grasping probe190 includes a pair of arms 192 which rotate about a hinge 194.Electrodes 196 are disposed between arms 192 and oriented so as toengage the surface of the tissue which is grasped by the arms.

[0126] A method for using grasping probe 190 is illustrated in FIGS. 25Aand 25B. In this embodiment, arms 192 engage abdominal fascia AF ofabdominal wall AW. Arms 192 grasp and draw a region of the tissue TRinward so as to reduce tension within the grasped region. Electrodes 196engage abdominal fascia AF within the tissue region TR, and a currentflux is directed between these electrodes to heat and shrink theabdominal fascia.

[0127] Preliminary work in connection with the present invention hasshown that a wall stress of 1.3 lbs. per linear inch can limit theshrinkage of some fascia to about 20%, rather than the 40% to 50%shrinkage observed when that fascial tissue is not in tension. Hence,the method illustrated in FIGS. 25A and 25B will find a variety ofapplications for shrinking tissues which would otherwise be undertension during the procedure. Specifically, the illustrated method maybe used during abdominoplasty (sometimes referred to as a “tummy tuck”)to selectively shrink the abdominal wall. By reducing tension in theabdominal tissues, the shrinkage provided from the application ofheating energy can be increased significantly. Alternatively, the amountof area treated to provide a particular reduction in length of thefascia can be minimized. If sufficient tissue is treated using such amethod, the waistline of the patient could be reduced by several inches.

[0128] Grasping probe 190 may also be used in a wide variety ofprocedures, and a variety of grasping structures might be used,generally by grasping a region of the tissue to be treated and pullingthe region inward to eliminate and/or reduce tension in the graspedregion. The grasped tissue should be free to shrink while grasped by theprobe, and the fascia should be exposed for contact with the bipolarelectrodes, or otherwise in a position to be heated by a heatingelement. In some embodiments, the grasped tissue may be heated by alaser, a monopolar radiofrequency electrode, a microwave antennae,focused ultrasound transducer, a heated probe surface, or the like. Thegrasped fascia may generally be heated by any heating element, and willshrink to a greater extent than would otherwise result from heatingtensioned fascia (or other collagenated tissue).

[0129] Grasping probe 190 may include a wide variety of alternativegrasping structures. In some embodiments, the ends of arms 192 mayinclude protruding points to penetrate into and more firmly grip thefascia. A vacuum mechanism may be used to grasp the tissue region TRbetween the arms, or discrete vacuum ports on each arm might be used.Arms 192 might slide (rather than pivot) relative to each other, andelectrodes 196 may be affixed to a single structure to maintain apredetermined interelectrode separation, and to limit tissue heatingdepth, as described above.

[0130] The devices and methods of the present invention will findparticularly advantageous applications for treatment of hernias, as canbe generally understood with reference to FIGS. 26 and 27. In FIG. 26, aportion of a stomach ST protrudes through an enlarged esophageal hiatusEH of a diaphragm D. This can lead to severe reflux, in which the acidicstomach juices are persistently regurgitated, eroding the wall of theesophagus and causing a burning pain. These symptoms are oftenaggravated by a defective lower esophageal sphincter LES. While suchconditions may be treated using known methods, particularly usinglaparoscopic Nissen fundoplication, these surgical procedures requiresignificant amounts of surgical experience and skill to be successful.Lack of experience in these specialized procedures can lead to severecomplications, including pneumothorax, dysphagia, recurrent reflux, andloss of motility, thereby making it difficult and/or impossible to eat.Hiatal hernias may include a tear in the diaphragm of between 1 and 5 cmadjacent hiatus EH.

[0131] To overcome these disadvantages, the hiatal hernia illustrated inFIG. 26 may instead be treated by selectively shrinking the fascia ofdiaphragm D. Using the methods and devices of the present invention, thediameter of esophageal hiatus EH can be decreased so that the diaphragmproperly contains the stomach. Specifically, stomach ST is repositionedbelow diaphragm D, and grasping probe 190 (illustrated in FIG. 24)grasps the upper or lower surface of diaphragm D adjacent the esophagealhiatus. A portion of the diaphragm adjacent the esophageal hiatus isdrawn inward, preferably circumferentially so as to decrease the size ofthe hiatus. The fascia of diaphragm D may then be heated and contractedto prevent stomach ST from again protruding through the diaphragm.Alternatively, probe 10 (illustrated in FIG. 1), or any of thealternative tissue contracting structures described herein, might beused, particularly where diaphragm D is not under tension duringtreatment.

[0132] To improve the competence of lower esophageal sphincter LES,fascia adjacent and external to the sphincter may be treated to closethe valve more effectively. In some embodiments, such as where a Nissenprocedure would normally be indicated, or where a reinforcing patchmight otherwise be placed over the defect to prevent recurrence of thehiatal hernia, the fascial covering of the top of the stomach SF and thecorresponding surface of the diaphragm SD may be treated to promote theformation of an adhesion between these surfaces (which will engage eachother once stomach ST is properly positioned below diaphragm D). Such anadhesion would decrease the likelihood of recurrence of the hiatalhernia, and may generally reinforce the defect.

[0133] A method for treating a hiatal hernia by forming a reinforcingadhesion can be understood with reference to FIGS. 26A-26C. Stomach STis dissected from the surrounding diaphragm D, with a dissected portionof the diaphragm DD often remaining affixed to the stomach by adhesionsAD, as illustrated in FIG. 26A. The resulting enlarged hole in diaphragmD is contracted by shrinking the collagenated diaphragm about the hole,as described above and as illustrated in FIG. 26B. To secure stomach STbelow the contracted diaphragm, the adjacent surfaces of the stomach andthe diaphragm are treated to promote formation of an adhesion ADZconnecting these tissues. The dissected diaphragm segment DD aboutstomach ST may be removed to reduce necking, or may be left in place. Aprobe PR treating a superior surface of stomach ST is illustrated inFIG. 26C. It should be noted that the resulting two treated, opposedsurfaces will generally develop adhesions, while the treatment of onlyone of the opposed surfaces will not reliably promote adhesionformation. Once diaphragm D is contracted to properly size esophagealhiatus EH, and once adhesion ADZ connects the diaphragm to the stomach,reoccurrence of the hiatal hernia is substantially inhibited.

[0134] The methods and devices of the present invention are alsosuitable for treatment of inguinal or abdominal hernias, as illustratedin FIG. 27. In inguinal hernia IH, a portion of the small intestine SIprotrudes through the inguinal canal IC adjacent the spermatic cord SC.Using the methods of the present invention, the abdominal wall adjacentthe deep inguinal ring DIR and/or adjacent the superficial inguinal ringSIR may be selectively contracted about the spermatic cord once thesmall intestine SI has been pushed back into the abdominal cavity.Selective shrinking of the fascial tissue about the spermatic cord willallow the fascial tissue to properly contain the abdominal organs, oftenwithout having to resort to sutures, patches, and the like. Where theabdominal wall is not torn adjacent the hernia, treatment will often bepossible without grasping and drawing the tissue inward, as thestretched tissue should not be under tension after the herniated bowelhas been repositioned within the abdomen. Work in connection with thepresent invention has found that even hernias resulting in small tearsof the fascial tissue can be corrected by shrinking using a laparoscopicprobe similar to that illustrated in FIG. 1. Preferably, such tears willbe less than 2 cm in length, ideally being under 1 cm. In someembodiments, particularly where extended tears of the fascial tissuehave been found, the selective shrinking of the present invention may becombined with suturing, patches, and other known hernia repairtechniques. Once again, where the abdominal wall is under tension duringthe treatment procedure, a grasping probe, such as that illustrated inFIG. 24, might be used to enhance the effective contraction of theabdominal wall.

[0135] Fascial tissue, once shrunk using the methods of the presentinvention, has nearly 20 times the strength needed to contain theintestines in place. Nonetheless, to prevent the treated tissue fromstretching or tearing during the healing process, a retention girdle RGmay be worn. Retention girdle RG may help contain the tremendous forcesgenerated by coughing sneezing, and the like, particularly for a periodof about 8 weeks after a selectively shrinking of the fascia.

[0136] The present invention optionally relies on inducing controlledshrinkage or contraction of a tissue structure which comprises orsupports portions of the patient's urethra. The tissue structure will beone that is responsible in some manner for control of urination andwhere contraction of the tissue structure will have the effect ofreducing urinary leakage. Exemplary tissue structures include theurethral wall, the bladder neck, the bladder, the urethra, bladdersuspension ligaments, the sphincter, pelvic ligaments, pelvic floormuscles, fascia, and the like. In one exemplary embodiment, a portion ofthe urethral wall at or near the urethral sling is heated to contracttissue and create a kink or crease in the wall which provides apreferential closure site for the urethra. In effect, it becomes easierfor the patient's weakened tissue support structures to close theurethra and maintain continence. In another exemplary embodiment, thesupporting tissues and ligaments are shortened to at least partiallyreverse the stretching and weakening that has resulted from pregnancy orother patient trauma. By selectively contracting one or more of thepubococcygeal, iliococcygeal and/or detrusor muscles, support of theureter and urinary sphincter can be substantially improved.

[0137] Tissue contraction results from controlled heating of the tissueby affecting the collagen molecules of the tissue. Contraction may occuras a result of heat-induced uncoiling as the collagen β-pleatedstructure and subsequent reentwinement as the collagen returns to bodytemperature. By maintaining the times and temperatures set forth below,significant tissue contraction can be achieved without substantialtissue necrosis.

[0138] While the remaining description is specifically directed at anenergy-applying probe introduced through the urethra of a femalepatient, it will be appreciated that the methods of the presentinvention can be performed with a variety of devices and systemsdesigned to deliver energy to tissue target sites resulting in heatingof the tissue and selective contraction of tissue support structures.The temperature of the target tissue structure can here be raised to avalue in the range from 70° C. to 95° C., for a time sufficient toeffect the desired tissue shrinkage. In these embodiments, thetemperature will be raised from ½ second to 4 minutes, optionally beingfrom 0.5 minutes to 4 minutes and often from 1 minute to 2 minutes. Thetotal amount of energy delivered will depend in part on which tissuestructure is being treated as well as the specific temperature and timeselected for the protocol. The power delivered will often be in therange from 1 W to 20 W, usually from 2 W to 5 W.

[0139] Referring now to FIG. 28, a heat-applying probe 210 comprises aprobe body 212 having a distal end 214 and a proximal end 216. Anelectrode 218 is disposed near the distal end 214 of the probe body 212and is connected via electrically conductive wires (not shown) extendingthe length of the body and out through a connector cable 220 having aplug 224 at its proximal end. Usually, a proximal handle or hub 226 isprovided at the proximal end 216 of the probe body 212. Conveniently,the hub 226 may include an arrow 228 indicating alignment of the probehub with the asymmetrically mounted electrode 218.

[0140] The electrode 218 is intended for delivering RF energy whenattached to a power supply 230 (FIG. 30) connected through the plug 224in cable 220. As shown in FIGS. 28 and 30, the single electrode 218 isintended for monopolar operation. The electrode 218 may be formed frommany conventional electrically conductive electrode materials, such asstainless steel, platinum, conductive plastic, or the like. The probemay be formed from any conventional medical catheter or probe material,including organic polymers, ceramics, or the like. Usually, the probebody will be sufficiently flexible to be introduced through the urethrawith minimal discomfort, but it would also be possible to utilizesubstantially rigid probes as well.

[0141] The energy-applying probe 210 could also be adapted for bipolaroperation by including two or more isolated electrode surfaces near itsproximal end 218 (with electrically isolated conductors to each of theelectrode surfaces). As shown in FIG. 28B, a plurality of axiallyspaced-apart electrode surfaces 218 a, 218 b, 218 c, and 218 d could beconnected with an alternating polarity. Alternatively, as shown in FIG.28C, a plurality of circumferentially spaced-apart electrodes 218 e, 218f, 218 g, and 218 h could also be connected with alternating polarity.Usually, each of the electrodes will be connected through the probe body212 by a single isolated wire or other conductor, terminating in theconnector plug 224. Thus, the multiple electrode configurations of FIGS.28B and 28C can be operated either in a monopolar or bipolar fashion,depending on how the power supply is configured.

[0142] A particular electrode configuration including a pair of axiallyspaced-apart electrodes 218 i and 218 j is illustrated in FIG. 28D. Thiselectrode configuration is intended for treating the urethral wall atlocations immediately upstream and downstream of the urethral sling.Typically, the electrodes will be spaced-apart by distance in the rangefrom 1 mm to 5 mm, preferably from 1.5 mm to 3 mm.

[0143] In all the electrode configurations of FIGS. 28-28D, the totalelectrode area will usually be in the range from 1 mm2 to 10 mm2,preferably from 2 mm2 to 6 mm2. Moreover, the electrodes will beconfigured to reduce or eliminate electrical current concentrations whenoperating in a radio frequency mode. Usually, the electrode surfaceswill be relatively smooth, and the edges will be insulated or protectedby the adjacent probe body 212. In this way, the electric field or fluxemanating from the electrodes 218 will be relatively uniform, resultingin generally even heating of the tissue which is contacted by theelectrode.

[0144] A further exemplary electrode embodiment is shown in FIG. 29.There, a plurality of circumferentially spaced-apart electrodes 230 aremounted on an inflatable balloon 232 at the distal end 234 of anenergy-applying probe 236. Each of the electrodes 230 will be connectedto a single or to multiple conductors running to the proximal end (notshown) of the energy-applying probe 236, in a manner similar to thatillustrated for probe 210. By mounting the electrodes 230 on a radiallyexpandable balloon or other expansion member (e.g., an expandable cage),the electrodes can be firmly contacted against an interior surface ofthe urethra. Moreover, the contact can be maintained as the urethralwall expands or contracts, depending on how the energy is applied.

[0145] Referring now to FIG. 30, use of the energy-applying probe 210for treating a target site TS in a urethra draining bladder B isillustrated. The probe 210 is inserted so that electrode 218 contactsthe target site TS, which is typically adjacent the urethral sling. Theelectrode may be positioned based on ultrasonic imaging, fluoroscopicimaging, or the like. Alternatively, the probe may be inserted to aknown depth using a scale formed on the exterior of the probe (notshown). After properly positioning the electrode 218, RF energy isapplied from power supply 230 typically at a level in the range from 1 Wto 20 W, usually from 2 W to 5 W. As illustrated, the electrode 218 is amonopolar electrode, and a counter electrode 240 will be attached to anexternal portion of the patient's skin. The counter electrode isconnected to the power supply 230 by an appropriate cable 242 and plug244. Energy is applied until the tissue temperature is reached andmaintained for a desired amount of time. Optionally, a temperaturesensor can be provided on the probe 210, and feedback control of theamount of energy being applied can be implemented. For example, athermal couple, a thermistor, or other temperature sensor can be mountedadjacent to or within the electrode 218. Alternatively, a penetratingelement (not shown) can be provided on the probe to enter beneath thesurface of the urethral wall by a preselected distance to measureinternal tissue temperature. Other known temperature control techniquescould also be utilized.

[0146] Referring now to FIGS. 31-33, a heat-applying probe 400 comprisesa probe body having a sheath component 402 and an electrode rodcomponent 404. The electrode rod 404 is reciprocatably mounted in alumen of the sheath 403 so that a distal electrode array 406 on the rod404 may be retracted and extended into and from the distal end 408 ofthe sheath 402. A proximal handle 410 is provided on the sheath, and aproximal connector 412 is provided on the electrode rod component 404.

[0147] The electrode array 406, as illustrated, includes four individualelectrode tips 420 each of which has a sharpened distal end suitable forpenetrating into tissue, particularly for transmucosal penetrationthrough the vaginal wall into the tissue structures which support theurethra or urinary sphincter. The electrode tips 420 are sufficientlyresilient so that they will be radially contracted when the rod 404 iswithdrawn proximally into the sheath 408. The electrode tips 420 willresiliently expand from the sheath when the electrode rod component 404is advanced distally when the sheath 408 is positioned near the tissuetarget site, as discussed in more detail below. As illustrated, theelectrode tips 420 are commonly connected to a single plug in theconnector 412. Thus, the probe 400 is only suitable for monopolaroperation. It will be appreciated, however, that the multiple electrodetips 420 could be connected through separate, isolated conductors withinthe rod 404 and further be connected through multiple pins in theconnector 412. Thus, the probe 400 could readily be adapted for bipolaroperation. Usually, all components of the probe will be insulated, otherthan the electrode tips 420. Alternatively, some other portion of therod 404 or sheath 402 could be formed from electrically conductivematerial and utilized as a common or indifferent electrode so that theprobe could be utilized in a bipolar manner. A variety of suchmodifications would be possible with the basic probe design.

[0148] Referring now to FIGS. 34-37, use of probe 400 for contractingtissue ligaments which support the urethra in the region of the urethralsling will be described. Initially, the treating physician manuallyexamines the vagina V to locate the region within the vagina beneath theurethral sling. The probe 400 is then introduced into the vagina.Conveniently, the physician may manually locate the probe, again byfeeling the region which is supported by the urethral sling. After thesheath 402 of the probe 400 is properly positioned, the rod component404 will be distally advanced so that the electrode tips 420 arepenetrated into the tissue which supports the urethra, typically thepubococcygeal muscles, iliococcygeal muscles or the detrusor muscle asillustrated in FIGS. 36 and 37. The physician will continue to use afinger F to hold the probe against the vaginal wall to facilitatepenetration of the electrode tips 420. RF energy can then be appliedthrough the probe in order to heat the target tissue to temperatures andfor time periods within the ranges set forth above. The supportingtissues are thus contracted in order to reduce urinary leakage andenhance patient continence.

[0149] The procedures of the present invention result in bulking andbuttressing of the supporting tissue structures as the tissue heal. Thisresult is in addition to the tissue contraction, with both thecontraction and tissue bulking/buttressing acting to enhance patientcontinence.

[0150] Referring now to FIG. 38, a kit 500 includes a tissue contractingprobe 502 and instructions for its use 504. Contracting probe 502 andinstructions 504 are disposed in packaging 506. Contracting probe 502here includes a structure similar to probe 10 of FIG. 1, but has aradially ended tip 54 to facilitate laparoscopically engaging theelectrode wires against both laterally and axially oriented tissues.Instructions 504 will often set forth the steps of one or more of themethods described herein above for treating urinary incontinence.Additional elements of the above-described systems may also be includedin packaging 506, or may alternatively be packaged separately.

[0151] Instructions 504 will often comprise printed material, and may befound in whole or in part on packaging 506. Alternatively, instructions504 may be in the form of a recording disk or other computer-readabledata, a video tape, a sound recording, or the like.

[0152] The present invention further encompasses methods for teachingthe above-described methods by demonstrating the methods of the presentinvention on patients, animals, physical or computer models, and thelike.

[0153] While the exemplary embodiment has been described in some detail,by way of illustration and for clarity of understanding, variousmodifications, adaptations, and changes will be obvious to those ofskill in the art. Therefore, the scope of the present invention islimited solely by the appended claims.

What is claimed is:
 1. A method for treating incontinence in a patient,said method comprising: inserting a probe into the patient; advancing aplurality of tissue-penetrating structures from the probe so that theelectrodes penetrate a collagenous tissue structure; and applying energyto the collagenous tissue structure with the tissue-penetratingstructures to heat the collagenous tissue structure sufficiently toeffect shrinkage of the collagenous tissue structure so that thecollagenous tissue structure inhibits incontinence.
 2. A method as inclaim 1, wherein the probe is inserted into a urethra of the patient. 3.A method as in claim 2, wherein the energy is applied as a bipolar RFenergy transmitted between the tissue-penetrating structures.
 4. Amethod as in claim 3, wherein an axis of the probe extends from theproximal end to the distal end with electrodes extending asymmetricallyrelative to the axis, wherein two electrodes deploy from the probe topenetrate the collagenous tissue structure on a first lateral side ofthe probe, and wherein two electrodes deploy from the probe to penetratethe collagenous tissue structure on a second lateral side of the probe.5. A method as in claim 1, wherein the collagenous tissue structurecomprises at least one member selected from the group consisting of aurethral wall, a bladder, a bladder neck, a ureter, bladder suspensionligaments, a sphincter, pelvic ligaments, pelvic floor muscles, andfascia.
 6. A method as in claim 3, wherein the collagenous tissuestructure comprises the bladder neck.
 7. A method as in claim 1, furthercomprising adjusting a power level of the energy, wherein the adjustingstep is performed in response to internal temperature in the collagenoustissue structure.
 8. A method for treating incontinence in a patient,said method comprising: inserting a probe into the patient; electricallycoupling at least one electrode of the inserted probe to a collagenoustissue structure; applying electrical energy to the collagenous tissuestructure with the at least one electrode to heat the collagenous tissuestructure; and controlling an amount of the energy applied in responseto a temperature of the collagenous tissue structure so that thecollagenous tissue structure inhibits incontinence.
 9. A method as inclaim 8, wherein the shrinkage includes apposition of circumferentiallyseparated regions of a urethral wall.
 10. A method as in claim 8,wherein the shrinkage provides a kink or closure point along the urethrato inhibit leakage.
 11. A method as in claim 11, wherein the energy isapplied so as to cause bulking and buttressing of the collagenous tissuestructure during healing.
 12. A method as in claim 9, wherein the energyis applied so as to effect shrinkage of the collagenous tissuestructure, the shrinkage and tissue bulking/buttressing acting toenhance patient continence.
 13. A system for treatment of incontinence,the system comprising: a probe body having a proximal end and a distalend, the distal end suitable for insertion into a urethra of a patientbody for positioning in alignment with to a collagenous tissuestructure; a plurality of electrodes near the distal end of the probebody, the electrodes reciprocatably mounted on the probe body so thatsaid electrodes are extendable from the probe body to penetrate into thecollagenous tissues; a connector disposed near the proximal end of theprobe body, the connector coupleable to a power supply for transmissionof electrical energy to the electrodes; and a controller coupled to thepower supply, the controller controlling an amount of the energy of thecollagenous tissue structure so as to heat the collagenous tissuestructure to a target temperature range such that the collagenous tissuestructure will inhibit incontinence.
 14. A system as in claim 13,wherein the probe body has an axis extending between the proximal endand the distal end, wherein the electrodes are asymmetrically disposedabout the axis, and wherein the electrodes are oriented toreciprocatably deploy into the collagenous tissue on generally opposedlateral sides of the probe body.
 15. A system as in claim 13, furthercomprising a sensor disposed near the electrode, the sensor measuringinternal temperature in the collagenous tissue.
 16. A system fortreatment of incontinence, the system comprising: a urethral probe bodyhaving a proximal end and a distal end, the distal end suitable forinsertion into a urethra adjacent to a collagenous tissue structure; atleast one electrode reciprocatably mounted near the distal end of theprobe body, the at least one electrode adapted to penetrate into thecollagenous tissue structure; a power supply coupled to said at leastone electrode for transmission of electrical energy therethrough; and afeedback controller coupled to the power supply, the controller limitingan amount of the energy in response to a temperature of the collagenoustissue structure so as to heat the collagenous tissue structure so that,when healed, the collagenous tissue structure inhibits incontinence. 17.A system as in claim 16, further comprising indicia of rotationalalignment disposed adjacent the proximal end of the probe forrotationally aligning the electrodes with the collagenous tissuestructure.
 18. A system as in claim 17, wherein an axis of the probeextends between the proximal and distal ends, and wherein the electrodesare asymmetrically disposed about the axis.